CoChat
Sign Up
Cited by 283Ethics in Clinical ResearchEthics and bioethics in healthcareQualitative Research Methods and Ethics

The DOI matches its Crossref record; 35 of the 36 references it cites were found in a registry or an index.

The concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines

Open access
Bracken-Roche, Dearbhail, Bell, Emily, Macdonald, Mary Ellen, Racine, Eric·2017·Health Research Policy and Systems
DOI 10.1186/s12961-016-0164-6PMC PMC5297186
Open this paper in CoChat — free accountOpen PDF

Abstract

BACKGROUND: The concept of vulnerability has held a central place in research ethics guidance since its introduction in the United States Belmont Report in 1979. It signals mindfulness for researchers and research ethics boards to the possibility that some participants may be at higher risk of harm or wrong. Despite its important intended purpose and widespread use, there is considerable disagreement in the scholarly literature about the meaning and delineation of vulnerability, stemming from a perceived lack of guidance within research ethics standards. The aim of this study was to assess the concept of vulnerability as it is employed in major national and international research ethics policies and guidelines. METHODS: We conducted an in-depth analysis of 11 (five national and six international) research ethics policies and guidelines, exploring their discussions of the definition, application, normative justification and implications of vulnerability. RESULTS: Few policies and guidelines explicitly defined vulnerability, instead relying on implicit assumptions and the delineation of vulnerable groups and sources of vulnerability. On the whole, we found considerable richness in the content on vulnerability across policies, but note that this relies heavily on the structure imposed on the data through our analysis. CONCLUSIONS: Our results underscore a need for policymakers to revisit the guidance on vulnerability in research ethics, and we propose that a process of stakeholder engagement would well-support this effort.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1186/s12961-016-0164-6

Cites

35 of 35 references verified0 citation errors · 0 not checkable

Statistics

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 36 references

Cited by

Sorted by citations

Items 201–282 of 282

Related

See all

Metadata

Authors
Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E.
Affiliations
  • Montreal Clinical Research Institute (CA)
  • McGill University (CA)
ORCID
Macdonald, Mary Ellen
Venue
Health Research Policy and Systems
Publisher
Springer Science and Business Media LLC
Published
2017-02-07
Volume
15
Issue
1
Pages
8-8
ISSN
1478-4505 (ISSN-L)
DOI
10.1186/s12961-016-0164-6
PMC
PMC5297186
OpenAlex
W2587319655
Cited by
283
References
36
Citations by year
2026: 23 · 2025: 29 · 2024: 29 · 2023: 47 · 2022: 42 · 2021: 38 · 2020: 28 · 2019: 24 · 2018: 9 · 2017: 10
FWCI
18.23
Type
journal article
Language
en
Update notices
correction (2017-04-03)
Open access
Licence
cc-by
Locations
  • Health Research Policy and Systems (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • eScholarship@McGill (McGill) (submittedVersion, cc-by)
Funders
  • Canadian Institutes of Health Research (97982)
  • Fonds de Recherche du Québec - Santé (30998)
  • Faculty of Medicine, McGill University (Internal Studentship 2015-16)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
  • Social Sciences › Sociology and Political Science › Qualitative Research Methods and Ethics
Keywords
research participant vulnerability, research ethics guidelines, Belmont Report, vulnerable populations, research ethics policy, research ethics committees, stakeholder engagement
MeSH terms
Clinical Trials as Topic, Health Policy, Humans, Informed Consent, International Cooperation, Practice Guidelines as Topic, Personal Autonomy, Ethics, Research, Biomedical Research, Vulnerable Populations

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review